Kidney capsule leaflet material

Patent metadata

Field	Value
Publication number	US-10231830-B2
Application number	US-201615340242-A
Country	US
Kind code	B2
Filing date	Nov 1, 2016
Priority date	Nov 10, 2015
Publication date	Mar 19, 2019
Grant date	Mar 19, 2019

Abstract

A prosthetic heart valve provided herein can include a kidney capsule tissue leaflet. In some cases, a prosthetic heart valve can include a plurality of leaflets secured together and retained within the expandable tubular member. The kidney capsule tissue can be obtained from a farm animal, such as a cow, pig, horse, goat, or sheep. In some cases, the kidney capsule tissue can be tensioned (e.g., bi-axially tensioned) and/or chemically cross-linked.

First claim

What is claimed is:

1. A prosthetic heart valve comprising a plurality of leaflets secured together and retained within an expandable tubular member, each leaflet comprising kidney capsule tissue,
wherein the kidney capsule tissue has been cross-linked while under a bi-axial tensioning to create a bi-axially oriented, cross-linked kidney capsule tissue that does not recoil when tension is released.

2. The prosthetic heart valve of claim 1 , wherein each leaflet comprises multiple layers of kidney capsule tissue.

3. The prosthetic heart valve of claim 1 , wherein the kidney capsule tissue is obtained from a farm animal.

4. The prosthetic heart valve of claim 1 , wherein the kidney capsule tissue is bovine kidney capsule tissue.

5. The prosthetic heart valve of claim 1 , wherein the kidney capsule tissue is porcine kidney capsule tissue.

6. The prosthetic heart valve of claim 1 , wherein the kidney capsule tissue is equine kidney capsule tissue.

7. The prosthetic heart valve of claim 1 , wherein the kidney capsule tissue is sheep kidney capsule tissue.

8. The prosthetic heart valve of claim 1 , wherein the kidney capsule tissue is goat kidney capsule tissue.

9. The prosthetic heart valve of claim 1 , wherein the kidney capsule tissue is chemically cross-linked with glutaraldehyde.

10. The prosthetic heart valve of claim 1 , wherein the kidney capsule tissue has a thickness of between 25 microns and 75 microns.

11. The prosthetic heart valve of claim 10 , wherein each leaflet has one or more layers of kidney capsule tissue to have a total thickness of between 50 microns and 0.33 mm.

12. The prosthetic heart valve of claim 1 , wherein the kidney capsule tissue has a moisture content of between 73% and 94%.

13. The prosthetic heart valve of claim 1 , wherein the kidney capsule tissue has an ultimate tensile strength of between 3.6 MPa and 8.0 MPa.

14. The prosthetic heart valve of claim 1 , wherein the kidney capsule tissue has a thickness of about 43 microns, a moisture content of about 86% and an ultimate tensile strength of about 6.8 MPa.

Assignees

• Boston Scient Scimed Inc

Inventors

• Swanson Lynne E
• Anderson-Cunanan Crystal Marie
• Fazackerley Katherine Cora
• Crompton Philip D

Classifications

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2/24

  Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body} · CPC title

• A61L27/3604

  characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2210/0076

  multilayered, e.g. laminated structures · CPC title